immunogenicity and safety of glaxosmithkline biologicals' mmrv vaccine vs. proquad® in children 12-14 months of age

Conditions: Varicella; Rubella; Mumps; Measles

Summary: the purpose of this observer blinded study is to provide information on vaccine immunogenicity and reactogenicity in comparison with the us standard of care (proquad®) when administered with hepatitis a vaccine and pneumococcal vaccine.


Eligibility criteria:
inclusion criteria: * subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol. * male or female between 12 and 14 months of age at the time of first vaccination. * written informed consent obtained from the parent/guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * have previously received 3 doses of 7-valent pneumococcal conjugate vaccine within the first year of life. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine. * previous vaccination against measles, mumps, rubella and/or varicella. * previous vaccination against hepatitis a or receipt of a fourth dose of pneumococcal conjugate vaccine. * history of measles, mumps, rubella and/or varicella/zoster diseases. * known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination, including human immunodeficiency virus infection. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures. uncomplicated febrile convulsions are not an exclusion criterion. * residence in the same household as the following persons: * new-born infants (0-4 weeks of age). * pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox. * pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history. * persons with known immunodeficiency. * acute disease at the time of enrolment. all vaccines can be administered to persons with a minor illness. * administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period. * contra-indications to commercially available vaccines used in this study (havrix®, prevnar®, proquad®).

Keywords: vaccines rubella varicella vaccine children humans mumps immunogenicity safety measles combined vaccine